Clinical Research Directory

MOms in REcovery (MORE) Study: Defining Optimal Care

Northern New England has among the highest rates of opioid dependence in the U.S. This region also has among the highest rates of opioid-related deaths in the U.S., with a disproportionate high rate among pregnant women with opioid use disorder. Newborns impacted by OUD have increased risk of poor outcomes, including preterm birth and long hospitalization for neonatal withdrawal and other newborn complications. For pregnant women with OUD, medication treatment (MOUD) significantly reduces these risks. Many maternity care providers have begun to prescribe MOUD in their practices. Other practices have maintained the longstanding evidence-based standard of care, referral of patients with OUD to specialty treatment programs. Most pregnant women with OUD have other psychosocial needs, ranging from lack of housing and untreated mental health conditions, to need for parenting education and support. There is variability among practices in terms of types of other services provided to patients. Although pregnancy is a time when women are highly motivated to start MOUD, many women are also likely to discontinue MOUD postpartum due to loss of insurance coverage, difficulty transitioning to another provider, loss of motivation for treatment, or competing demands on time and resources as a new parent. The challenge for patients, providers, and other stakeholders is to understand the relative advantage of the two MOUD models (receiving MOUD as part of maternity care or at a specialty program) for improving key outcomes for baby \& mother. A second challenge is to understand the relative contributions of onsite services such as mental health care, care coordination and parenting education to improved outcomes. Addressing these challenges is particularly important in rural areas where obstetric practices \& specialty care services are limited. Patients, providers \& other stakeholders need guidance in choosing the optimal models for building programs to provide maternity care for women with OUD.

Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.

Hepatic Energy Fluxes in NASH and NAS Patients

Diseases along the nonalcoholic fatty liver disease spectrum, which are tightly coupled to the obesity epidemic, are soon to become the commonest indication for liver transplantation in the United States. Bariatric surgery shows great promise in the treatment of these diseases. The studies proposed herein will be the first to measure in humans the relationships among (i) the liver's ability to burn fat and make glucose, two of its primary functions; (ii) the severity of nonalcoholic fatty liver disease; and (iii) the responses to bariatric surgery. These experiments will support deeper future mechanistic investigations of the metabolic mechanisms underlying nonalcoholic steatohepatitis (NASH) improvement with bariatric surgery. The premise of this study is that deranged hepatic mitochondrial metabolism is a key biomarker and mediator of the nonalcoholic fatty liver disease (NAFLD)/NASH continuum, and the central hypothesis the investigators will test is that preoperative hepatic fat oxidation and glucose production flux parameters differ between low versus high NAFLD activity score (NAS), and response of the liver to bariatric surgery can be predicted by preoperative fluxes.